New draft on Monacolin K
Existence of a new draft European Commission Regulation amending Annex III of Regulation (EC) No. 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice.
Monacolin K is an active compound naturally present in red yeast rice. This is chemically identical to some cholesterol medications.
This compound is currently included in Regulation (EC) No. 1925/2006 of the European Parliament and of the Council.
The reason for its modification is carried forward to 2010. At that time, they asked AESAN to issue an opinion to inform health claims regarding monacolin K. From this point on, potential safety issues related to food consumption began to be raised.
Finally, based on the opinion presented by the French National Agency for Food, Environmental and Occupational Safety (ANSES), the Authority concluded that the available information on adverse effects reported in humans was sufficient to state that monacolins from red yeast rice in their use as food supplements posed a risk to human health. serious security problem.
We have been verbally informed that this is currently a draft that will be published and implemented shortly. This would initiate the procedure to include a substance or an ingredient containing a component other than a vitamin or a mineral in Annex III of the aforementioned regulation, which establishes the list of substances whose use in food is prohibited, restricted or subject to control by the Union.
From Legalego Food Consulting, we will continue to inform you of any legislative developments that are approved or processed by the various agencies and authorities responsible.
The draft of this new European Commission Regulation can be consulted here.